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Found 36 results for label/kegiatan.
UK Achieves Site Activation World Record for Roche During COVID-19 Pandemic
The UK’s Urgent Public Health response has been applauded by global life science company, Roche, as COVACTA, an international COVID-19 trial, closes to recruitment in nine countries.
Moving Toward the Implementation Deadline – Approaching MDR Compliance
In this blog post, PPD regulatory affairs experts discuss the MDR and provide suggestions to device manufacturers to support compliance.
Estimands in Oncology Trials
PPD’s cross-functional estimands working group explores how the ICH E9 addendum impacts oncology clinical trials.
The Value of Patient Experience Data
Qualitative interviews can generate meaningful patient data to inform trial design and gain deeper understanding of treatment experience.
European Union Clinical Trials Regulation: Clinical Trials Information System
PPD experts explain the key features of the Clinical Trials Information System (CTIS), which has been introduced alongside the new EU CTR.
The Present and Future of Conditional Regulatory Authorization and Access Pathways for Cell and Gene Therapies
Advanced therapy medicinal products (ATMPs) represent one of the more promising therapeutic development lines.
Moderna and Thermo Fisher Scientific Win TOPRA Award for Regulatory Excellence for COVID-19 Vaccine Authorization
The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, and Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, have won a 2022 TOPRA Award for Regulatory Excellence.